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Sterisart® System for Liquids in Closed, Large Volume Containers

The Sterisart® NF System is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filtration method but eliminates the procedure of manipulating filters. As such, risk of a secondary contamination (and false-positive results) is eliminated.

Top Features of the Sterisart® NF System:

  • Guaranteed sterile barrier for aseptic septum sampling
  • Gas-impermeable, color- and bar-coded packaging
  • Adapters for use of the Sterisart® NF System in all pumps

Popular Applications for the Sterisart® NF System:

  • Sterility testing of sterile pharmaceuticals and medical devices

Item no.:  16466--------GBD

Price (USD):  $505.00

 

* 24 Hours Turnaround Time

The Sterisart® NF System is a single-use technology, based on the membrane filtration method, for the sterility testing of pharmaceutical products. By providing 15 different units, technicians can selectively choose which adapter or system best fits their application. The Sterisart® Universal Pump transfers the sample into the filtration units. After rinsing, the filtration units are filled with culture media and used for incubation of the filters without any contact to the environment. After 14 days of incubation, a visible result is available (turbidity | no turbidity).

Dual-Needle Metal Spike for easy and safe piercing

The Sterisart® NF System comes with a patented dual-needle metal spike with an in-built venting filter and a protective shield, making sampling secure and unencumbered. Built-in sterile venting ensures safe interaction with closed sample containers.

Safe, User-Friendly Operation

Intuitive handling has never been easier with the Sterisart® NF System’s color-coded tube clamps, preinstalled to make your work straightforward. Color- and bar-coding keeps items organized, while the gas-impermeable packaging feature means units are free from contaminants. Raised sterile venting with safety clearance prevents accidental clogging and minimizes secondary contamination. The outlet plugs are directly housed in a niche in the primary packaging and the extra-large, grip optimized filter plugs are pre-tethered to the vent filters for easy use with isolator gloves.

Aseptic sampling and supplementation

The septum port of the Sterisart® canisters have been purpose-built to aseptically draw samples for rapid sterility testing, intermediate testing, sub-culturing, and for supplementation with antibiotic inactivators. The port ensures a sterile barrier, while minimizing the risk of puncture injuries. Our meticulously controlled quality testing ensures the system is fully compliant with USP 71, Ph. Eur. 2.6.1 and JP 4.06.

Accessories Information

  • Adapter
    Dual Needle

Applications

  • Application
    Sterility Testing
  • Laboratory Working Area
    Isolator
  • Market
    Pharma/Biotech

Dimensions

  • Filtration Area
    15.7 cm²

Features

  • Device/Instrument Compatibility
    • Sterisart® Universal Pump
    • Sterisart® Universal Pump, without display
  • Sampling Option
    No

General Specifications

  • Capacity of the Sampling Containers
    120 mL (graduation marks at 50, 75 and 100 mL)
  • Design
    Long dual-needle spike, sterile vented

Operating Conditions

  • Operating Pressure
    20 °C: 3 bar

Physicochemical Information

  • Pore Size
    0.45 µm
  • Pore Size Air Filter
    0.2 µm PTFE, validated acc. to HIMA for the retention of Brev. diminuta

Product Information

  • Brand
    Sterisart®
  • Container Type
    Large Volume Glass Bottles >30 ml
  • Pack Size
    10
  • Package Type
    Individually Packed
  • Sample Type
    LVPs

Sterility

  • Delivery Condition
    Sterile
  • Sterilization Method
    Gamma irradiation
Sterisart® Universal Pump, without display

$12,660.00

Sterisart® universal pump for sample and media transfer into the Sterisart® NF systems for sterility tests. The peristaltic pump can be used in clean rooms, integrated into clean benches, or installed countersunk in the working surface of isolators. Sterisart® universal pump is available as an upgraded version with display and user software. The sterility test system features a compact design with a space-saving footprint - a great benefit for most clean room benchtops and isolators.

Minisart® Syringe Filter, Polytetrafluorethylene (PTFE), Pore Size 0.2 µm, Ethylene Oxide, Female Luer Lock, Needle (38 × 1.7 mm), Pack Size 50

$270.00

Minisart® Air with chemically inert hydrophobic PTFE is suitable for venting as well as filtration of gases and oils with a pH of 3 - 12. Type 16596HNK with a pore size of 0.2 µm can be used for sterile filtration. It has an outlet with needle. Version HNK is individually packed and sterilized by ethylene oxide (EO).